Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-18 @ 1:33 AM
Study NCT ID:
NCT01669161
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2012-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '6-weeks', 'description': 'Assessment of adverse events and serious adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Upper', 'Limb', 'Deficits', 'Rehabilitation', 'VNS'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '26645257', 'type': 'RESULT', 'citation': 'Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.'}], 'seeAlsoLinks': [{'url': 'http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_471670.pdf', 'label': 'Abstract presented at the International Stroke Conference (ISC)'}]}, 'descriptionModule': {'briefSummary': 'Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior\n2. Age \\> 18 years and \\< 80 years\n3. Right or left sided weakness of upper extremity\n\nMajor Exclusion Criteria:\n\n1. Hemorrhagic stroke\n2. Any deficits in language or attention that interferes with reasonable study participation\n3. Presence of significant apraxia\n4. Profound Sensory loss\n5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01669161', 'briefTitle': 'Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroTransponder Inc.'}, 'officialTitle': "A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)", 'orgStudyIdInfo': {'id': 'Mt-St-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VNS', 'description': 'VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.', 'interventionNames': ['Device: Vivistim System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rehab Only', 'description': 'Rehabilitation only (no implant, no VNS)', 'interventionNames': ['Other: Rehab Only']}], 'interventions': [{'name': 'Vivistim System', 'type': 'DEVICE', 'otherNames': ['VNS, vagus nerve stimulation, paired VNS'], 'description': 'The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.', 'armGroupLabels': ['VNS']}, {'name': 'Rehab Only', 'type': 'OTHER', 'description': 'Rehabilitation without device implant and VNS', 'armGroupLabels': ['Rehab Only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow, Scotland', 'country': 'United Kingdom', 'facility': 'U. Glasgow / Western Infirmary'}], 'overallOfficials': [{'name': 'Jesse Dawson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U. Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroTransponder Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}